UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018474
Receipt number R000021342
Scientific Title Cardiovascular prognostic coupling study in Japan
Date of disclosure of the study information 2015/07/29
Last modified on 2019/08/01 10:05:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Cardiovascular prognostic coupling study in Japan

Acronym

Cardiovascular prognostic coupling study in Japan(Coupling Registry)

Scientific Title

Cardiovascular prognostic coupling study in Japan

Scientific Title:Acronym

Cardiovascular prognostic coupling study in Japan(Coupling Registry)

Region

Japan


Condition

Condition

Cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to clarify the relationship between the blood pressure variability and vascular properties in hypertensive, and to investigate its relationships with the onset of cardiovascular events in patients at high risk of cardiovascular disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to major cardiovascular events*.
*Major cardiovascular events; a composite of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke,
myocardial infarction, cardiovascular intervention due to angina pectoris, and sudden death.

Key secondary outcomes

1. Time to various events onset*.
* In addition to each component of major cardiovascular events, followings are considered as "various events": hospitalization by angina pectoris; hospitalization by heart failure, aortic dissection; occlusive arteriosclerosis; end stage renal insufficiency; doubling of serum creatinine values; new onset of atrial fibrillation; dementia; need of nursing care; total death.
2. Change in blood pressure
3. Increase of CAVI or ABI value.
4. Development of left ventricular hypertrophy
5. Adverse event


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with at least one of the following cardiovascular risk factor:
1. Diabetes, glucose tolerance disorder
2. Dyslipidemia
3. high-normal normotension and grade I - III hypertension (>130/85 mmHg)
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Past history of cardiovascular disease (coronary artery disease, cerebrovascular disorder or non-cardiogenic cerebrovascular disorder, aortic dissection, peripheral artery disease, history of hospitalization by heart failure)
7. atrial fibrillation
8. Metabolic syndrome
9. Chronic obstructive pulmonary disease
10. Sleep apnea syndrome

Key exclusion criteria

1. Patients with chronic renal failure in haemodialysis
2. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease)
3. Alcohol addiction
4. Drug addiction
5. Patients who cannot visit a hospital alone by walk
6. Patients who cannot give informed consent by themselves
7. Patients who are judged to be inappropriate for the study by physician

Target sample size

7000


Research contact person

Name of lead principal investigator

1st name Kazuomi
Middle name
Last name Kario

Organization

Jichi Medical University School of
Medicine

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

329-0498

Address

3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.

TEL

0285-58-7344

Email

kkario@jichi.ac.jp


Public contact

Name of contact person

1st name Kazuomi
Middle name
Last name Kario

Organization

Jichi Medical University School of

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

329-0498

Address

3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.

TEL

0285-58-7344

Homepage URL


Email

coupling@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University School of
Medicine

Institute

Department

Personal name



Funding Source

Organization

Community Medicine Cardiovascular
Research Asia IT Network Center,
Division of Cardiovascular Medicine
Jichi Medical University School of
Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

FUKUDA DENSHI CO.,LTD.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical School clinical study support center

Address

3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.

Tel

0285-58-8933

Email

rinri@jichi.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

鷲谷病院(栃木県)、フクダ電子株式会社(東京都)、今別町国民健康保険今別診療所(青森県)、
沖縄県立中部病院(沖縄県)、遠賀中間医師会おんが病院(福岡県)、かわしま循環器内科(栃木県)、
久保田クリニック(東京都)、小竹町立病院(福岡県)、東吾妻町国民健康保険診療所(群馬県)、
藤田脳神経外科医院(香川県)、南三陸病院(宮城県)、山際クリニック(愛知県)、
周防大島町立東和病院(山口県)、岩国市医療センター医師会病院(山口県)、
まつい内科クリニック(山口県)、石橋内科医院(茨城県)、阿部内科医院(兵庫県)、
佐久総合病院佐久医療センター(長野県)、南和歌山医療センター(和歌山県)、表参道内科眼科(東京都)、
JCHOうつのみや病院(栃木県)、富士通クリニック(神奈川県)、
馬渡島診療所(佐賀県)、八代市椎原診療所(熊本県)、国民健康保険大間病院(青森県)、
大島診療所(福岡県)、国際医療福祉大学病院(栃木県)、結城病院(茨城県)、新小山市民病院(栃木県)、
とちぎメディカルセンターしもつが(栃木県)

 


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

6068

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 26 Day

Date of IRB

2015 Year 03 Month 26 Day

Anticipated trial start date

2015 Year 07 Month 29 Day

Last follow-up date

2027 Year 10 Month 31 Day

Date of closure to data entry

2028 Year 01 Month 31 Day

Date trial data considered complete

2028 Year 03 Month 31 Day

Date analysis concluded

2029 Year 03 Month 31 Day


Other

Other related information

This is a prospective cohort study.
Follow up period: Seven years.
Patients are followed up regularly for seven years every one year from a registration day.


Management information

Registered date

2015 Year 07 Month 29 Day

Last modified on

2019 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021342


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name